The Netherlands-based medtech Xeltis has presented trial results for its aXess haemodialysis access graft showing 0% infection rates at 12 months.
The data from the aXess-FIH trial (NCT04898153) was presented at the 50th Annual VEITHsymposium in New York on 16 November.
Haemodialysis access, also called vascular access, is a way to reach the blood for dialysis. It can be done by multiple means namely, through a fistula, graft, and catheter. The choice of access depends on the longevity of the method and its ability to cause fewer infections.
The vascular access device for the haemodialysis market is forecasted to be worth $936.6m in 2030, as per GlobalData analysis. The vascular access graft subsection of the market is forecasted to be worth $633.6m in the same period.
aXess vascular graft was developed using Xeltis’ proprietary endogenous tissue restoration (ETR) platform that utilises biodegradable polymer. It dissolves over time and creates a new, long-term living vessel for haemodialysis vascular access. This has the potential to minimise complications and infections.
The single-arm feasibility study enrolled 20 patients aged 18 years and older with end-stage renal disease and was deemed unsuitable for fistula creation across multiple European sites. As of 17 November, over 3,500 dialysis sessions have been conducted across the trial sites.
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The 20 patients demonstrated 100% secondary patency and 78% primary assisted patency at 12 months. This data was similar to the six-month results showing 80% primary patency, 95% primary assisted patency, and 100% secondary patency. The graft patency was defined as any flow through both the graft and the native vessel.
Xeltis is also conducting a larger single-arm, non-randomised pivotal trial (NCT03022708) evaluating the aXess haemodialysis vascular access graft. The study expects to enrol 110 patients over 25 sites across Europe. As of 17 November, more than 40 trial participants have already received access graft. The study is expected to be completed in December 2026, as per ClinicalTrials.gov.
This year, Xeltis has raised €44.5m ($48.3m) in Series D2 funding round to advance clinical development of its implants.